Duns Number:216344051
Device Description: ALLEVYN Ag Adhesive 3in x 3inSilver Wound Dressing
Catalog Number
66020970
Brand Name
ALLEVYN Ag Adhesive 3in x 3in
Version/Model Number
66020970
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K063835,K063835,K063835
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
37ac7103-daa8-487e-aabb-4acc827f8f36
Public Version Date
June 22, 2021
Public Version Number
5
DI Record Publish Date
July 04, 2019
Package DI Number
05000223459789
Quantity per Package
10
Contains DI Package
05000223459772
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 63 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 126 |
| U | Unclassified | 1 |